MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE

MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE is an FDA 510(k)-cleared medical device (K990863) manufactured by Ross Product Div. Abbott Laboratories. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 5, 1999. Regulation: 8.